Last reviewed · How we verify
Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Phase 2 trial testing E/C/F/TDF in Acquired Immunodeficiency Syndrome in 279 participants. Completed in 22 August 2016.
| Lead sponsor | Gilead Sciences |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 279 |
| Start date | 28 December 2011 |
| Primary completion | 17 October 2012 |
| Estimated completion | 22 August 2016 |
| Sites | 41 locations across Puerto Rico, United States |
Gilead Sciences — full company profile →
18 and older, any sex, with Acquired Immunodeficiency Syndrome or HIV Infections. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
| Group | Value | 95% CI |
|---|---|---|
| E/C/F/TAF | 88.4 | |
| E/C/F/TDF | 89.7 |
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
| Group | Value | 95% CI |
|---|---|---|
| E/C/F/TAF | 88.4 | |
| E/C/F/TDF | 87.9 |
| Group | Value | 95% CI |
|---|---|---|
| E/C/F/TAF | 4.63 | ± 0.572 |
| E/C/F/TDF | 4.69 | ± 0.577 |
| Group | Value | 95% CI |
|---|---|---|
| E/C/F/TAF | -3.20 | ± 0.654 |
| E/C/F/TDF | -3.26 | ± 0.606 |
| Group | Value | 95% CI |
|---|---|---|
| E/C/F/TAF | -3.22 | ± 0.606 |
| E/C/F/TDF | -3.33 | ± 0.572 |
| Group | Value | 95% CI |
|---|---|---|
| E/C/F/TAF | 404 | ± 181.6 |
| E/C/F/TDF | 394 | ± 209.6 |
| Group | Value | 95% CI |
|---|---|---|
| E/C/F/TAF | 165 | ± 115.6 |
| E/C/F/TDF | 179 | ± 127.7 |
| Group | Value | 95% CI |
|---|---|---|
| E/C/F/TAF | 177 | ± 144.1 |
| E/C/F/TDF | 204 | ± 120.4 |
Time frame: Up to 186.2 weeks plus 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | E/C/F/TAF | E/C/F/TDF | All E/C/F/TAF |
|---|---|---|---|---|
| Appendicitis | Infections and infestations | — | — | — |
| Bipolar disorder | Psychiatric disorders | — | — | — |
| Depression | Psychiatric disorders | — | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — | — |
| Cellulitis | Infections and infestations | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Suicidal ideation | Psychiatric disorders | — | — | — |
| Cardiac failure acute | Cardiac disorders | — | — | — |
| Coronary artery disease | Cardiac disorders | — | — | — |
| Myocardial infarction | Cardiac disorders | — | — | — |
| Pericarditis | Cardiac disorders | — | — | — |
| Colitis | Gastrointestinal disorders | — | — | — |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | — | — | — |
| Large intestine perforation | Gastrointestinal disorders | — | — | — |
| Pancreatitis | Gastrointestinal disorders | — | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — | — |
| Non-cardiac chest pain | General disorders | — | — | — |
| Systemic inflammatory response syndrome | General disorders | — | — | — |
| Clostridium difficile colitis | Infections and infestations | — | — | — |
| Coxsackie viral infection | Infections and infestations | — | — | — |
| Cytomegalovirus colitis | Infections and infestations | — | — | — |
| Erysipelas | Infections and infestations | — | — | — |
| Furuncle | Infections and infestations | — | — | — |
| Hepatitis C | Infections and infestations | — | — | — |
| Reaction | System | E/C/F/TAF | E/C/F/TDF | All E/C/F/TAF |
|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Syphilis | Infections and infestations | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Bronchitis | Infections and infestations | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — |
| Fatigue | General disorders | — | — | — |
| Sinusitis | Infections and infestations | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Depression | Psychiatric disorders | — | — | — |
| Gastroenteritis | Infections and infestations | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — |
| Pharyngitis | Infections and infestations | — | — | — |
| Influenza | Infections and infestations | — | — | — |
| Hyperlipidaemia | Metabolism and nutrition disorders | — | — | — |
| Conjunctivitis | Infections and infestations | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Chlamydial infection | Infections and infestations | — | — | — |
| Toothache | Gastrointestinal disorders | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — |
| Procedural pain | Injury, poisoning and procedural complications | — | — | — |
| Osteopenia | Musculoskeletal and connective tissue disorders | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Hypogonadism | Endocrine disorders | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — |
| Seasonal allergy | Immune system disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — |
| Acarodermatitis | Infections and infestations | — | — | — |
| Abnormal dreams | Psychiatric disorders | — | — | — |
| Paraesthesia | Nervous system disorders | — | — | — |
| Flatulence | Gastrointestinal disorders | — | — | — |
| Anorectal human papilloma virus infection | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
Most-reported serious reactions: Appendicitis, Bipolar disorder, Depression, Acute myocardial infarction, Cholelithiasis, Cellulitis, Pneumonia, Suicidal ideation.
Data from ClinicalTrials.gov NCT01497899 adverse events section.
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.
4 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01497899.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing